Consensus Panel, National Guidelines, and Other Potentially Misleading Terms

management program would hire and train community residents to help overcome language and cultural barriers to obtaining access to care for Medicaid recipients with depression and cardiovascular disease. The “savings” would apparently be measured in reduced emergency room visits and hospitalizations. The Pharmaceutical Research and Manufacturers of America (PhRMA) contested the Florida Medicaid program efforts to extract “supplemental” rebates, but a federal judge in the U.S. District Court in northern Florida (Tallahassee) ruled on December 28, 2001, that the Florida Medicaid list of preferred drugs may influence patient and physician behavior but did not prevent access to nonpreferred drugs, which would be illegal under federal law. In September 2002, the Eleventh Circuit Court of Appeals (Atlanta) upheld the lower court’s ruling regarding the Florida program, and the legality of Medicaid supplement rebate programs based upon PDLs with prior authorization was bolstered by the decision from Federal Court Judge John Bates in Washington, DC, on March 28, 2003, regarding a similar program in Michigan that employed a PDL with prior authorization. The value of disease management programs in lieu of concessions in direct drug cost was disputed by a report from the Office of Program Policy Analysis & Government Accountability (OPPAGA) of the Florida legislature in early 2003. OPPAGA found that the disease management programs in Florida sponsored by prescription drug manufacturers saved the state about $35M in 2002, about $30M short of the amount that the drug companies would have paid in supplemental rebates. In 2001, Florida’s PDL saved the state $123M, including $46M (37.4%) from supplemental rebates. OPPAGA recommended to the Florida legislature that supplemental rebates be required for all drugs on the PDL and that the disease management programs be funded from a portion of the supplemental rebate income. OPPAGA analysts also said that the methodologies used by the drug companies to calculate savings from the disease management programs were vague, and some experts opined that the drug manufacturers had not been able to show that their disease management programs save money despite offering these programs to health insurers and others since the mid-1990s. From another perspective, it is easy to see why the pharmaceutical manufacturers are opposed to the heavy-handed managed care method imposed by prior authorization (PA). The PA process in Florida produced dramatic market share changes that would be the envy of managed care pharmacists in the private sector. In just 90 days, the market share of lansoprazole increased by an absolute 21 percentage points, or 55% in relative terms, from 38% of prescriptions for proton-pump inhibitors in the second quarter of 2001 to 59% of prescriptions for proton-pump inhibitors in the third quarter of 2001. Lansoprazole market share increased further, to 67% of prescriptions in the fourth quarter of 2001. Stated another way, by paying supplemental rebates, the manufacturer of lansoprazole was able to nearly double its market share, a relative increase of 76%, or 29 absolute percentage points, in just 6 months, at the expense of competitor omeprazole, which experienced a market share drop of 33 percentage points, from 49% in the second quarter of 2001 and to 16% in just 90 days in the third quarter of 2001. The market share erosion for omeprazole was essentially 100%, to a residual of 1% of prescriptions for proton-pump inhibitors in the first quarter of 2002, a period of just 9 months.

management program would hire and train community residents to help overcome language and cultural barriers to obtaining access to care for Medicaid recipients with depression and cardiovascular disease. The "savings" would apparently be measured in reduced emergency room visits and hospitalizations. The Pharmaceutical Research and Manufacturers of America (PhRMA) contested the Florida Medicaid program efforts to extract "supplemental" rebates, but a federal judge in the U.S. District Court in northern Florida (Tallahassee) ruled on December 28, 2001, that the Florida Medicaid list of preferred drugs may influence patient and physician behavior but did not prevent access to nonpreferred drugs, which would be illegal under federal law. 26 In September 2002, the Eleventh Circuit Court of Appeals (Atlanta) upheld the lower court' s ruling regarding the Florida program, and the legality of Medicaid supplement rebate programs based upon PDLs with prior authorization was bolstered by the decision from Federal Court Judge John Bates in Washington, DC, on March 28, 2003, regarding a similar program in Michigan that employed a PDL with prior authorization. 27 The value of disease management programs in lieu of concessions in direct drug cost was disputed by a report from the Office of Program Policy Analysis & Government Accountability (OPPA-GA) of the Florida legislature in early 2003. OPPAGA found that the disease management programs in Florida sponsored by prescription drug manufacturers saved the state about $35M in 2002, about $30M short of the amount that the drug companies would have paid in supplemental rebates. In 2001, Florida' s PDL saved the state $123M, including $46M (37.4%) from supplemental rebates. OPPAGA recommended to the Florida legislature that supplemental rebates be required for all drugs on the PDL and that the disease management programs be funded from a portion of the supplemental rebate income. 28 OPPAGA analysts also said that the methodologies used by the drug companies to calculate savings from the disease management programs were vague, and some experts opined that the drug manufacturers had not been able to show that their disease management programs save money despite offering these programs to health insurers and others since the mid-1990s. 29 From another perspective, it is easy to see why the pharmaceutical manufacturers are opposed to the heavy-handed managed care method imposed by prior authorization (PA). The PA process in Florida produced dramatic market share changes that would be the envy of managed care pharmacists in the private sector. In just 90 days, the market share of lansoprazole increased by an absolute 21 percentage points, or 55% in relative terms, from 38% of prescriptions for proton-pump inhibitors in the second quarter of 2001 to 59% of prescriptions for proton-pump inhibitors in the third quarter of 2001. 30 Lansoprazole market share increased further, to 67% of prescriptions in the fourth quarter of 2001. Stated another way, by paying supplemental rebates, the manufacturer of lansoprazole was able to nearly double its market share, a relative increase of 76%, or 29 absolute percentage points, in just 6 months, at the expense of competitor omeprazole, which experienced a market share drop of 33 percentage points, from 49% in the second quarter of 2001 and to 16% in just 90 days in the third quarter of 2001. The market share erosion for omeprazole was essentially 100%, to a residual of 1% of prescriptions for proton-pump inhibitors in the first quarter of 2002, a period of just 9 months.

II Disease Management, Pay-for-Performance, and Clinical Pharmacist Interventions in Diabetes Care
The April 2003 issue of a business news magazine contained 2 articles on the same subject, but the editor did not make an apparent connection between the articles and their common subject. More surprising, both articles were written by the same author. Certainly, the titles of the articles were different and would not suggest a connection: "Pay-for-performance plans seek to cut costs," 31 and "Pharmacist oversight cuts cost of chronic disease." 32 One article touted the "unique" notion of paying physicians to attain certain measures of disease management, in an employersponsored program called "Bridges to Excellence." The separate, front-page article, touted the value of pharmacists in managing chronic disease, particularly diabetes; incidentally, the pharmacists were compensated for the professional interventions. The former article reported that several large employers had invested in a scheme, labeled Bridges to Excellence, with the intended purpose of reducing future costs of chronic disease, specifically diabetes. The (physician) pay-for-performance program had the same expected outcomes as the pay-pharmacist program, the regular, routine use by patients of measures to better control serum glucose and thereby delay the onset and reduce the magnitude of complications of diabetes.
The pharmacist pay-for-outcomes program, the "Asheville Project," involved payment of $38 per monthly visit to participating pharmacists who monitor medication adherence and the routine use of serum glucose measures and perform basic physical exams to detect foot care or other health problems that may warrant a medical visit to a physician. The City of Asheville, a primary sponsor of the pay-pharmacist disease management program for diabetes, reported savings of $2,000 per diabetic patient per year, largely as a result of reduced hospital costs. Average total medical costs per diabetic patient were reported to be $7,082 prior to implementation of the pharmacist disease management program for diabetes, an average $5,210 (26% less) in the first year and $4,651 in year 2, a 34% reduction compared to base-year costs. The Asheville Project included incentives for patient participation, including the elimination of copayments for visits to pharmacists and diabetes drugs and supplies, and provided each participating patient with a glucose meter.

II Consensus Panel, National Guidelines, and Other Potentially Misleading Terms
A recent article trumpeted in its title, "Consensus Panel Recommendations" for "Asthma Treatment Guidelines." 33 The Editorial Subjects-In This Issue panel of 16 physicians and 2 pharmacists appeared to have the credentials necessary to adequately address the subject. However, the work of the panel and the article that was derived from this work were funded by the manufacturer of the drug that the panel recommended for use in patients with moderate to severe asthma that is "suboptimally controlled." This observation gives the reader pause. Should not national treatment guidelines be based upon evidence from randomized clinical trials and developed by independent experts who do not benefit from or have a direct commercial interest in the recommendations that evolve from such panels?
What is the necessary amount of independence for these experts? Some may argue that experts employed by health plans are biased toward treatments and care processes that are concerned about cost. On the other hand, physicians and other providers engaged in clinical practice generally want what is best for their patients and may have little interest in cost, particularly for insured patients. Disclosure of potential conflicts of interest and sources of funding is a fundamental tool to manage bias, but most would agree that consensus panel guidelines should not be developed by persons compensated by the company that stands to benefit from the use of these guidelines. For busy readers, perhaps such treatment guidelines should include titles such as "Consensus Panel Recommendations Sponsored by XYZ Company."